Exploring why, in fully outsourced clinical trial models, visibility across data systems can be less a technology question than a process one
Understanding where data signals can fall through the gaps when multiple CROs and vendors have their own internal processes, review cadences and timelines
Case study: a pharmacokinetic protocol deviation that never reached the sponsor because it fell between chairs in the communication chain
Case study: a screen failure cleaning exercise where a site misinterpretation of instructions led to an irreconcilable discrepancy
Exploring how stronger oversight frameworks and clearer agreement on what is expected, and from whom, could prevent these issues
Asking what we should be considering before adopting a new digital tool – recognising that a tool can integrate systems, but not always processes
How patient centered digital measures can capture meaningful changes in health and daily life that traditional, episodic clinical assessments may miss
How continuous, real-world wearable data can help assess whether improvements during standardized in-clinic tests translate into meaningful changes in patients’ daily live
Real world case examples demonstrating how fit for purpose digital measures can reveal treatment signals, functional changes, and patient relevant outcomes that standard approaches may not fully capture
Why successful patient-centered digital measurement requires thoughtful study design, fit-for-purpose algorithms, continuous compliance monitoring, and high-quality data
Practical guidance for advancing digital measures from exploratory use toward clinically meaningful endpoints while maintaining patient relevance throughout clinical development
What changes for sponsors when EHDS, eIDAS 2.0 wallets, the Data Governance Act and the AI Act converge on clinical trial data infrastructure.
Why current consent and audit-trail architectures will not survive a participant’s right to revoke or port their data, and what the Nordic region is already building as the working answer: consent evidence ledgers, privacy-preserving computation, and neutral data altruism intermediaries
